Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Coagulants

Vitamins

Acetic Acid

Retinol acetate

Lugol's solution

A team made up of a Community Health Worker (CHW) and a nurse will do door-to-door sensitization and propose to eligible women to undergo HPV self-sampling test at home. Samples collected will be taken by the nurse to the hospital for HPV testing . Participants will receive a phone call: disclosure of the HPV test's result will be by phone call for HPV-negative participants; HPV-positive participants will be invited to the hospital for disclosure of their results. At the hospital, HP-positive participants will undergo visual assessment of their cervix and treatment if needed.

Community Health Worker (CHW) will do door-to-door sensitization and invite eligible women to attend cervical cancer screening at District Hospital Dschang. At the hospital they will do HPV self-sampling test. HPV-negative women will be advised to repeat the test after 5 years while HPV positive women will undergo visual assessment of the cervix with acetic acid and lugol (VIA/VILI) and treatment if needed.

Counseling on cervical cancer screening followed by home-based HPV self-sampling test proposal.

Experimental

Counseling on cervical cancer screening followed invitation to screen at Dschang District Hospital.

Active comparator

Patrick Petignat, Pr

Bruno Kenfack, Pr

Cervical cancer is a public health problem in Cameroon.In 2020, the country had a crude incidence of 20.2 per 100 000 women for an incidence to mortality ratio of 0.65. As for now, the country does not have a national screening program to combat the disease. Only 6% of cameroonian women have once been screened for cervical cancer. In order to increase screening uptake so as to reach 70% recommended by the World Health Organization (WHO), a home-based cervical cancer screening approach is proposed. The objective of our study is to compare two recruitment strategies for cervical cancer screening in rural Cameroon.

In 2018, a 5 years cervical cancer screening project called: "Promoting Comprehensive Cervical Cancer Prevention and Better Women's Health in Low- and Medium Resource Settings in the Health District of Dschang" was launched in the West Region of Cameroon. The study aimed at screening 2000 women per year following screen-triage-treatment as recommended by WHO in a 3T approach: Test with HPV self-sampling test, Triage by visual assessement of the cervix with acetic acid and lugol (VIA/VILI), Treatment with thermal ablation. Despite sensitization using communication information channels, uptake of the screening was below the target. In order to increase uptake of the screening, this study proposes a home-based strategy using Community Health Workers (CHW). Community Health Workers (CHW) are lay members of the community who carry out health promotion activities after training. In a randomised controlled cluster trial, two recruitment strategies for cervical cancer screening will be compared: in one arm a team made up of a CHW and a nurse will do door-to-door sensitization and propose home-based HPV self-sampling test to eligible women and in the other arm CHW will do door-to-door sensitization and issue invitation cards to eligible women for hospital-based HPV self-sampling test. This study is nested in ongoing cervical cancer screening project.

Primary objective: To compare completeness of full screening between two different recruitment strategies in rural area: counselling and home-based HPV self-sampling test versus counselling and hospital-based HPV self-sampling test.

Secondary objectives:

* To determine the proportion of women who will carry out an HPV self-sampling test in both strategies within 3 months of sensitization.
* To determine the proportion of HPV positive women who will undergo VIA/VILI in both arms within 3 months.
* To assess the acceptability of home self-sampling HPV test and perception of single versus 2 visits approaches.
* To determine predictors of non-adherence to care-seeking for HPV positive women.
* To determine the number of pre-cancers and/or cancers diagnosed in both arms and their treatment.
* To calculate the economic cost of both strategies.

Mixed method design, quantitative and qualitative informations will be collected.

Two arms randomised controlled cluster trial

Home-based Cervical Cancer Screening Project

Offering Home-based Versus Hospital-based HPV Counseling and Testing for Cervical Cancer Screening in Rural West Region of Cameroon: a Randomised Cluster Trial

Anonymised data may be shared upon reasonable request at the end of the study period.

The number and percentage of participants who will do an HPV self test+/- VIA/VILI+/- treatment par study arm

The number and percentage of participants who will do an HPV test in each arm of the study.

The number and percentage of participants once tested HPV positive who link to the hospital for visual assessment of the cervix and treatment if needed.

Factors that prevent and motivate women to participate to a home-based HPV self-test.

Factors that prevent and motivate participants who did a home-based HPV self-test to link to the hospital for visual assesment of the cervix using acetic acid and lugol (VIA/VILI).

The number of pre-cancers and cancers diagnosed per study arm.

The cost of each strategy and make a cost-effectiveness analysis.

Dschang District Hospital

Prof. Patrick Petignat

Professor

Skin and Connective Tissue Diseases

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Imiquimod

LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications

LFX453 0.15% liquid crystal cream (LCC) Twice daily applications

Vehicle to nanomedicinal cream (NMC) Twice daily applications

Vehicle to liquid crystal cream (LCC) Twice daily applications

Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.

Investigational Treatment

Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up.

Novartis Pharmaceuticals

This is a randomized, vehicle controlled, active comparator, parallel group, study with a total duration of 24 weeks including screening and follow-up. Study drug is applied topically for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study endpoints are blinded to treatment allocation.

Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients

A Randomized, Vehicle Controlled, Active Comparator, Parallel Group Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Topical LFX453 Formulations in Patients With Actinic Keratosis

Number of participants with at least one AE/SAE in the category up to 20 weeks

Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined

Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined

Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined

Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at 8 weeks after the end of treatment (Week 20 = EOS visit) for LFX453 compared to vehicle groups combined

Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined

Reduction rate (percent) of Actinic keratosis (AK) lesion count at Week 8 for LFX453 compared to vehicle groups combined

LFX453 0.1% NMC

LFX453 0.15% LCC

Vehicle to NMC

Vehicle to LCC

Aldara

Total

Age, Continuous

Sex: Female, Male

Study Director

Adverse Events (AEs)

Serious Adverse Events (SAEs)

The safety analysis set included all patients that received any study drug. For Safety \& Tolerability only the 2 vehicles have separate analysis.

Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks

Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications

Combined Vehicle

Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.

Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined

Week 8

Week 16

Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined

Number of Participants That Had Partial Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined

Number of Participants That Partial Clearance of Actinic Keratosis (AK) at at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined

Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined

Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at Week 8 for LFX453 Compared to Vehicle Groups Combined

Overall Study

Blood and Lymph Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid, Chronic-Phase

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

cohort 3: Imatinib through dosage ≥ 1000 ng/ml

Cohort 2 : Imatinib standard dose Imatinib through dosage \< 1000 ng/ml

Cohort 1 : dose adjustment based on trough plasmatic level value Imatinib through dosage \< 1000 ng/ml

Posology dose modification

active comparator

Imatinib mesylate (Gleevec/Glivec, IM) is currently the gold standard or CML-CP front line therapy. The recommended dose of IM is 400 mg/day. The rates of complete cytogenetic responses at 3, 6 and 12 months are 27%, 50% and 69% respectively. The optimal IM daily dose is not yet determined and randomized studies addressing this question are on-going. First results from the TOPS trial (EHA 2008 congress) suggest a more rapid kinetic of response for patients treated with imatinib high dose. Recent studies revealed that initial Imatinib plasmatic dosage is predictive for achieving complete cytogenetic responses (CCR) and that a dosage of 1000 ng/ml is associated with a higher proportion of major molecular responses (MMR) (Picard et al., Blood 2007, Larson et al. Blood 2007).

Results from the study of Larson et al. indicate that around 40% of the patients had a trough plasmatic level below 1000 ng/ml after day 28 of imatinib 400 mg/d. The major molecular response rate at 12 months for the patients with the lower plasmatic through level is 25.4% compared to 40.1% for the patients with a plasmatic dosage over 800 to 1000 ng/ml.

Investigators propose to adapt the imatinib daily dose in case of imatinib through plasmatic level at day 28 below 1000 ng/ml. Patients with a trough plasmatic dosage ≤ 1000 ng/ml will be randomized between a prospective adaptation strategy of the imatinib daily dose (cohort 1) versus observation only (cohort 2). The patients with adequate imatinib dosage (\> 1000 ng/ml) will be followed up according the ELN recommendation (cohort 3). Imatinib trough plasmatic level will then be rechecked every month thereafter for patients in cohort 1 and cohort 2 and every three months in cohort 3. The first endpoint of the study will be the rate of major molecular response at 12 months in cohort 1. Our hypothesis is to improve the 12 months MMR rate with the optimized strategy (cohort 1) from 25% of MMR at 12 months to 40% of MMR at 12 months.

A Prospective Randomized Phase II Study Evaluating the Monitoring of Imatinib Mesylate Plasmatic Through Level in Patients Newly Diagnosed With CP-CML

A Prospective Randomized Phase II Study Evaluating the Monitoring of Imatinib Mesylate (Glivec®) Plasmatic Through Level in Patients Newly Diagnosed With Chronic Phase Chronic Myelogenous Leukaemia (CP-CML).

Versailles Hospital

Study coordonator

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Bevacizumab

Capecitabine

Antimetabolites

SCRT: 5\*5Gy for 5 days, after a one-week rest, with fruquintinib plus sintilimab followed; Fruquintinib: qd po, 4mg/d, 2weeks on/1 week off, q3w; Sintilimab: intravenous infusion, 200mg, on day 1, q3w.

Capecitabine: bid po, 1000mg/m², on days 1-14, q3w; Bevacizumab: intravenous infusion, 7.5mg/kg, on day 1, q3w.

Active Comparator

Ji Zhu, M.D.

Zhong Shi, M.D.

Wangxia Lv, M.D.

The aim of this study is to evaluate the efficacy and safety of short course radiotherapy followed by fruquintinib combined with Sintilimab as the first-line treatment of advanced mCRC compared to bevacizumab combined with capecitabine in patients unfit for intensive therapy.

Anti-angiogenic therapy combined with immune checkpoint inhibitors in advanced mCRC has shown promising efficacy with acceptable toxicities. Radiotherapy may reshape the tumor immune microenvironment, thereby improving the efficacy of subsequent anti angiogenic drugs combined with immunotherapy.

The study is a prospective, multi-centered, two-stage clinical study with 220 unresectable advanced mCRC patients unfit for oxaliplatin or irinotecan-based intensive chemotherapy enrolled. In phase 1b, 20 patients will be recruited and the efficacy and safety of SCRT followed by fruquintinib plus sintilimab will be explored. In phase 2, 200 patients will be randomized and the efficacy and safety will be compared between SCRT followed by fruquintinib plus sintilimab and capecitabine plus bevacizumab.

Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine as First Line Treatment in Advanced mCRC

An Open-label, Multi-centered, Two-stage Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine in the First Line Treatment of Advanced mCRC Patients Unfit for Intense Therapy

ORR according to RECIST v1.1, as assessed by the Investigator

PFS according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the Investigator

Number of Participants With Treatment-emergent Adverse Events (TEAEs) according to CTCAE v5.0

DCR according to RECIST v1.1, as assessed by the Investigator

OS according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the Investigator

Zhejiang Cancer Hospital

Gland and Hormone Related Diseases

Syndrome

Infertility

Polycystic Ovary Syndrome

Anovulation

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

Micronutrients

Bone Density Conservation Agents

Mineral

Metformin

Vitamin D

Cholecalciferol

Calcium

Calcium, Dietary

Progesterone

Trace Elements

Vitamin D3

Calciferol

Calcium Supplement

Experimental Group (Group A; n=71):

The intervention (experimental) group will receive VD injections 600,000 I.U I/M once with 1 gram calcium supplemental daily in the initial 12 weeks. After that standard PCOS care; i) Glucophage XR 750 mg (once for 15 days then twice daily) ii) progesterone supplementation (1 capsule Progeffik 100 mg every 3 weeks, then 1 week off) and iii) calcium supplements will be given for next 12 weeks.

Control Group (Group B; n=71):

Participants will receive standard PCOS treatment; Glucophage XR 750 mg once at dinner for 15 days then twice daily and Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off for initial-- 12 weeks.

Then VD supplementation (600,000 IUI/M) will be given once during the study period with Calcium 1000 mg/day and continued Standard PCOS treatment from 12- 24 weeks

Intervention Group Initial 12 weeks;

* VD supplementation (600,000 IU I/M) once during the study period
* Elemental calcium 1000 mg/day From 12-24 weeks: Standard PCOS;
* Glucophage XR 750 mg once at dinner for 15 days then twice daily
* Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off
* Calcium 1000 mg/day

Active Comparator (Group B; n=71):

Initial-- 12 weeks;

* Standard PCOS;
* Glucophage XR 750 mg once at dinner for 15 days then twice daily
* Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off From 12- 24 weeks
* VD supplementation (600,000 IUI/M) once during the study period
* Calcium 1000 mg/day
* Standard PCOS Continued

Rehana Rehman, PhD

Poly cystic Ovarian Syndrome (PCOS) is an endocrine disorder of reproductive age defined by "the presence of any two out of three criteria: oligo and/or anovulation, excess androgen activity and/or polycystic ovarian morphology on ultrasound". Considering role of vitamin D (VD) (3, 4) and high prevalence (58%) of deficiency in PCOS of Pakistan. Researchers hypothesized that its correction would improve response to standard PCOS treatment. The objective is to compare PCOS parameters in intervention group (Group A) receiving VD supplementation and then PCOS care with control group (Group B) receiving standard PCOS care and then VD supplementation. A randomized open label trial: delayed-start design will be conducted on VD deficient PCOS females VD \< 20ng/ml ; Group A will receive VD injections 600,000 I.U I/M once with 1 gram calcium supplement daily in the initial 12 weeks. After that standard PCOS care; i) Glucophage XR 750 mg (once for 15 days then twice daily) ii) progesterone supplementation (1 capsule Progeffik 100 mg every 3 weeks, then 1 week off) and iii) calcium supplements will be given for next 12 weeks. PCOS females in Group B will receive standard PCOS care (same) with addition of VD and calcium supplementation after 12 weeks till study end point. Study outcomes will be comparison of i) hyperandrogenism by Free Androgen Index \[Total Testosterone, Steroid Hormone Binding Globulin ii) insulin Resistance by HOMA-IR (serum Insulin, Fasting Blood Glucose) and iii) oxidative stress by Total Antioxidant Capacity after 24-weeks in these Groups'd levels after supplementation will be assessed for confirmation of correction and calcium and albumin levels for detection of hypercalcemia. Results of this study will inform the clinicians to add VD before or after the standard PCOS care for rectification of endocrine and metabolic derangements as a cost-effective treatment and prevention strategy in these females.

This study will comprise of two groups (A and B) with 71 participants in each group carried for a duration of 24 weeks.

Intervention Details for Group A (Duration 1-12 weeks):

Participants will be given Vitamin D (VD) supplementation at a dose of 600,000 IU along with Calcium 1000 mg/day.

Mid-Point (At 12 weeks):

Patients will have a consultation for clinical interpretation. They will undergo biochemical assessment, including the estimation of Insulin Resistance, Free Androgen Index, and Total Antioxidant Capacity.

After 12 weeks They will receive standard treatment for Polycystic Ovary Syndrome (PCOS), which includes Glucophage XR 750 mg once at dinner for 15 days, then twice daily. Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off and Calcium 1000 mg/day

Intervention Details for Group B (Duration 1-12 weeks):

Participants in Group B will receive standard PCOS treatment mentioned earlier:

Glucophage XR 750 mg once at dinner for 15 days, then twice daily. Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off. Additionally, they receive Calcium 1000 mg/day.

Mid-Point (At 12 weeks):

Patients will have a consultation for clinical interpretation. They will undergo biochemical assessment, including the estimation of Insulin Resistance, Free Androgen Index, and Total Antioxidant Capacity.

Intervention Details for Group A (After 12 weeks)

They will receive VD supplementation (600,000 IU) during this time and continue to receive Calcium 1000 mg/day.

Calculations of HOMA-IR and Free Androgen Index will be done at 12 and 24 weeks and the results will be compared.

{HOMA-IR: HOMA- IR index, a commonly used marker of IR, will be calculated using the formula: HOMA-IR = fasting glucose levels \[mmol/L\] × fasting insulin levels \[μU/mL\]/22.5 Free Androgen Index will be derived from TT and SHBG, normally measured in nanomoles per liter. FAI =100 (TT /SHBG)}

Infertile females with Polycystic Ovarian Syndrome

Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome

Efficacy of Vitamin D Supplementation in Females With Polycystic Ovary Syndrome: a Randomized Open Label Delayed-start Design

hyperandrogenism by Free Androgen Index \[Total Testosterone, Steroid Hormone Binding Globulin

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Home-based Cervical Cancer Screening Project	NCT06166420	Cervical Cancer	Experimental Active comparat...	30 Years - 49 Years	University Hospital, Geneva
Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients	NCT02404389	Actinic Keratos...	Investigational... Active comparat...	18 Years - 75 Years	Novartis
A Prospective Randomized Phase II Study Evaluating the Monitoring of Imatinib Mesylate Plasmatic Through Level in Patients Newly Diagnosed With CP-CML	NCT02896842	Leukemia, Myelo...	Posology dose m... active comparat...	18 Years -	Versailles Hospital
Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine as First Line Treatment in Advanced mCRC	NCT06195670	CRC Metastatic Colo... Metastatic Colo...	Experimental Active Comparat...	18 Years - 85 Years	Zhejiang Cancer Hospital
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome	NCT06045351	Anovulatory Inf...	Vitamin D Active Comparat...	18 Years - 45 Years	Aga Khan University
Epidemiological Assessment of the Risk for Pancreatic Cancer Associated With the Use of Semaglutide in Patients With Type 2 Diabetes - A Cohort Study Based on Nordic Registry Data	NCT04572165	Diabetes Mellit...	Ozempic® Active Comparat... Rybelsus®	18 Years -	Novo Nordisk A/S
Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients	NCT02404389	Actinic Keratos...	Investigational... Active comparat...	18 Years - 75 Years	Novartis
Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial	NCT04510597	Metastatic Clea... Metastatic Rena... Stage IV Renal ...	Cytoreductive N... Active Comparat...	18 Years -	SWOG Cancer Research Network

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